Guidelines for Submitting Research Protocols to Barry University Institutional Review Board

These guidelines comprise an overview of how and where to submit a research proposal for review by the
Institutional Review Board (IRB). The Barry University document, Policy and Procedures for the Protection
of Human Subjects in Research (see Faculty Handbook), provides in depth information concerning the principles,
definitions, policies, and implementation procedures for the protection of human subjects, based on
compliance with the U.S. Department of Health and Human Service's regulations.

Protocol Submission

WHO should submit

Any research involving human subjects which is conducted under the auspices of Barry University must
meet the requirements of Barry University for the protection of human subjects. In some instances, compliance
with the human subjects policies of the federal government and other agencies may be required. Accepting
funds or utilizing subjects and/or other resources from an outside agency obligates the researcher to
abide by the policies of that agency in addition to those of Barry University. This includes human subjects
Protocols.

Research activities covered by this policy include the following:

the research that is sponsored by this institution, or research that is conducted by or under the direction
of any employee or agent of this institution in connection with his or her institutional responsibilities,
or in which he or she has authorization to list this institution as his or her university affiliation,
or

research that is conducted by or under the direction of any employee or agent of this institution using
any property or facility of this institution, or

research that involves the use of his institution's non-public information to identify or contact human
research subjects or prospective subjects.

excepted from this policy is research specified as exempt for 45 CFR 46.101.b and/or research conducted
by students as exercises in courses designed to reach research methodology, provided that the research
is not to be disseminated beyond that class, external funding is not involved, and the appropriate School
or Department ensures human subject protection through its own internal review processes and informed
consent procedures consistent with 45 CFR 46.

WHEN to submit

In order for your protocol to be reviewed during a particular month, your materials must be submitted
no later than the first Friday of that month (see IRB homepage for dates). The above materials may be
submitted in person or they may be sent through campus mail to the office of the Vice President for
Academic Affairs. PROTOCOLS MUST BE RECEIVED NO LATER THAN 12:00 PM ON THE FIRST FRIDAY OF THE MONTH.

The IRB meets from 1:00 to 4:00 P.M. on the third Wednesday of most months of the year. Investigators
are encouraged to attend the IRB meetings in order to clarify any particular aspect of their protocol.

Where to file

Decisions and Appeals

Investigators will be notified in writing of the IRB's decision regarding any research protocol involving
human subjects. The submitted protocol will be placed into one of the following categories based on
the IRB's decision:

Exempt. An exempt research protocol is that which falls under a category that is exempt from IRB review
as described by the Code of Federal Regulations, Title 45, Part 46. (https://wayback.archive-it.org/) Such research includes several
forms of educational research, anonymous or non-sensitive social survey involving adults, observational
research involving adults, anonymous archival research, study of public records, and study of programs
under the Social Security Act or other public benefits or social service programs. Note: It is the policy
of Barry University that ALL research associated with Barry University be submitted for full IRB review.
If a research protocol is deemed exempt during the full review, no further IRB action or annual review
is required. If changes are made to the protocol, it is the responsibility of the investigator to contact
the IRB chair who will determine whether the protocol remains in exempt status.

Approved*. An approved research protocol is one that assures the protection of the
rights and safety of human subjects. Research may proceed once approval has been made by the IRB. It
is the responsibility of the investigator to submit an annual report to the IRB, and report any changes
made to the protocol, and report any injury or unanticipated problems involving risks that occurred
during the research.

* IRB approval of a protocol signifies approval only of the procedures for protecting
the rights and safety of human subjects. Evaluation of other aspects of the research (e.g., subject
matter, methodology, or experimental design) does not fall within the purview of the IRB.

Accepted pending changes. A protocol will be accepted once the required changes are made to the protocol.
A list of required changes will be sent to the investigator. The appropriate changes must be submitted
to the IRB chair before approval can be given. Research cannot proceed until the required changes are
met.

Rejected. The IRB rejects a research protocol when: 1) risks to subjects are greater than minimal or
are unreasonable relative to the benefits; 2) rights of the subjects are not protected; 3) subject selection
is inequitable; 4) inappropriate consent forms or no consent forms are included; 5), inadequate provisions
are made to protect the privacy of the subjects; 6) the protocol involves coercion of subjects; or 7)
pertinent information necessary for review is missing. A rejected protocol may be resubmitted as
a new protocol for full IRB review.

Any decision reached by the IRB may be appealed by the investigator. (See the Policy and Procedures for
the Protection of Human Subjects in Research section in the Faculty Handbook.) If the investigator anticipates
that objections may be raised about the protocol, the IRB chair may be consulted beforehand to prevent
delays in the approval process.

Follow Up

Investigators are required to report to the IRB any adverse effects, additional risks, or injury to human
subjects occurring during the course of the research. The IRB will conduct continuing review of ongoing
research at least once a year.

General Guidelines for Protocol Submission

All proposals submitted to this committee must adhere to the following outline of information:

Title of Project

Principal Investigator(s) include School and Department, mailing address, email address and phone number.
Principal investigator may be a student or faculty. ( If Barry student or faculty, include student number
or faculty number.)

Faculty Sponsor (If applicable). Include School and Department, mailing address, email address and phone
number. Faculty member who supervises the research of a student assumes responsibility for accurate
completion of the protocol and consent form, and for the annual report to the IRB.

Funding Agency Name and address of funding agency, if funding is being solicited.

Proposed Project Dates Projected dates of the beginning and completion of the proposed research. Please
allow time for approval when determining your start date. It is best if the end date you choose is one
year after the start date.

IMPORTANT NOTE: Do not begin the process of data collection until you have received
formal approval by the IRB. Failure to do so may result in disapproval of the project in question.

ABSTRACT (200 words or less)In nontechnical terms, summarize the problem being addressed. State general goals as well as the specific
aims of the study. Include the general methods to be used, with emphasis on sampling procedure and data
collection.

RECRUITMENT PROCEDURESExplicitly describe how participants will be enlisted for your study. (If participants are patients
in a hospital setting, they should be contacted by someone from that setting to ask if they would be
willing to talk with you about being in your study. If you are a staff member in that setting, you may
contact them directly.) If participants are potentially vulnerable to an undue influence, explain the
safeguards you will take to protect their rights. (See the Policy and Procedures for the Protection
of Human Subjects in Research section in the Faculty Handbook.) If using an advertisement to solicit
participants, include the wording to be used in the ad.

METHODSExplicitly describe everything the participants will be asked to do so that the IRB can evaluate risk/stress.
Do not refer the reader to an attached Methods section from a thesis. The IRB does not evaluate the
appropriateness of the methodology except to determine the relative risks to participants and how it
impacts completeness of the consent form in explaining risks and requirements.

ALTERNATIVE PROCEDURESBefore the potential participant agrees to participate in the study, explain what other choices (for
treatment, medication, exercise regime, etc.), if any, are available. Remember, an alternative to
your study is that the potential participant may withhold participation.

BENEFITSAvoid exaggerating benefits in order to encourage participation. For example, if direct benefit to the
subject is minimal or absent, use a general statement such as: "Although there may be no direct benefit
to you, it is hoped that the research may help us learn more about the benefits of physical activity."

RISKSGive your appraisal of any risks that might be involved and how they will be minimized. Minimal risk
means that the probability and magnitude of harm or discomfort anticipated in the research are not greater
in and of themselves than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests.

ANONYMITY AND CONFIDENTIALITYIf the study is indeed intended to be anonymous, no names or other identifiers may be collected on any
of the instruments used. You must include a cover letter (as opposed to a signed consent form) stating
that the data will be completely anonymous, explaining that no names will be requested. Confidentiality
(see below) is generally assured when the data are collected anonymously. If names are required for
any purpose in the process of data collection, the study is not anonymous. You must, in this case, indicate
how you will protect the participant's confidentiality. For example: "Data will be coded so that no
names will be used. Findings of the study will be published using group averages. No one will be identified
by name."

Policy concerning identifying links

In instances where identifiers linking research participants and their data exist, special efforts must
be taken to keep such identifiers apart from the data in order to provide confidentiality of participants.
To safeguard participant identities, researchers should separate signed consent forms from the data
and store the consent forms, together with codes or other identifiers, in a locked file cabinet. It
is imperative that the signed consent forms and codes or other identifiers not be located with stored
data. Consent forms must be retained by investigators for a period of five years. If the investigator
leaves Barry University prior to the end of the five years, consent forms must be kept at Barry University
(NOTE: This statement does not address retention of data.). If participants will be audio- or videotaped,
state what will happen to the tapes once the study is completed.

Consent of Participants

All participants in research should know the following:

That they will be participating in research

That their participation is voluntary

Exactly what they will be asked to do

How much time will be involved

Approximate number of participants in the study

That they may decline or discontinue participation at any time without negative consequences

Any potential risks and what assistance will be provided in the event of injury

How their confidentiality will be maintained when results are reported

Who is conducting the study, and who will be available to answer questions about the study (faculty
sponsor's name and number must be included)

Fate of any audio- or videotapes used, following completion of the study

Verbal Consent/Cover Letter

If the proposed research entails no risk to the participant AND anonymity is intended, a signed consent
form should NOT be used. You must instead include in your IRB application a cover letter for the participant
to read. This must contain all the usual elements of a signed consent form (other than the issue of
confidentiality), except for the signature line, and must be submitted in lieu of the standard written
consent form.

Written and Signed Consent

To ensure that the consent form is complete, use the Consent
Form Checklist. If you plan to enlist children 7-17 years of age, include both a parental consent
form (the signature of one parent is required) and a children's assent form. If the participant is a
minor child under age 7, only consent of the parent or legal guardian need be obtained. In the case
of research involving FDA-regulated products, information that the FDA and the study sponsor may inspect
records identifying participants must be clearly presented.

The consent form must be free of any exculpatory language through which the participant is made to waive
any legal rights, including any release of the investigator, the sponsor, the institution, or its agents
from liability for negligence.

The consent form must include a place for signatures of the participant and the primary investigator.

Documentation

All records relating to the research must be retained for at least five years after completion of the
data collection. All records (including consent forms), including audio- and videotapes that have not
been destroyed and transcribed notes from recordings must remain accessible for IRB inspection.

Meeting Calendar

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